UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031898 |
|---|---|
| Receipt number | R000036388 |
| Scientific Title | Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2020/11/16 11:29:36 |
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Basic information
Public title
Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression
Acronym
Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression
Scientific Title
Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression
Scientific Title:Acronym
Evidence Synthesis, Practice Guidelines and Real-World Prescriptions of New Generation Antidepressants in the Treatment of Depression
Region
| Japan | North America | Europe |
Condition
Condition
major depressive disorder
Classification by specialty
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the gaps between the ideally synthesized evidence, guideline recommendations and real-world clinical practices in the prescription of new generation antidepressants for major depression through the past three decades.
Basic objectives2
Others
Basic objectives -Others
This is a meta-epidemiologic study, which compares the difference between cumulative network meta-analysis, guideline recommendations and real world prescriptions.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ranking of antidepressants based on efficacy and acceptability by means of cumulative network meta-analysis. Ranking of recommended antidepressants in main guidelines in America and Europe. Ranking of real-world prescription of antidepressants based on American database MEPS.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with major depressive disorder, adults, both sex.
Key exclusion criteria
Patients with bipolar disorder and psychotic depression.
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Toshi A |
| Middle name | |
| Last name | Furukawa |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Health Promotion and Human Behavior, School of Public Health
Zip code
606-8501
Address
Floor 2, G Buiding, Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto, JAPAN
TEL
+81-75-753-9491
furukawa@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yan |
| Middle name | |
| Last name | Luo |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Health Promotion and Human Behavior, School of Public Health
Zip code
606-8501
Address
Floor 2, G Buiding, Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto
TEL
+81-75-753-9491
Homepage URL
lilacluo@gmail.com
Sponsor or person
Institute
Department of Health Promotion and Human Behavior, School of Public Health, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JSPS Grant-in-Aid for Scientific Research (Grant Number17k19808)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Ethics Commitee
Address
Kyoto University Graduate School of Medicine, Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
+81-75-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
It is an epi-epidemiologic research based on cumulative network meta-analysis.
Management information
Registered date
| 2018 | Year | 03 | Month | 26 | Day |
Last modified on
| 2020 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036388
